LIDOCAINE- lidocaine cream 
Nivagen Pharmaceuticals, Inc.

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Lidocaine 5%

Drug Facts

Active Ingredient

Lidocaine 5% w/w

Purpose

Topical anesthetic

Uses

Temporarily relieves the pain and itching due to anorectal disorders.

Warnings

For external use only.

When using this product

  • avoid contact with eyes
  • do not use in large quantities, particularly over large surfaces or blistered areas
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor.

Other Information

Store at 25°C (77°C); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

benzyl alcohol,carbomer hompolymer type C, C10-18 triglycerides, cholesterol, lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopherol, trolamine, water

Questions?

1-877-977-0687

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

NDC 75834-141-30

Lidocaine 5%
Topical Anesthetic Cream-Anorectal

NIVAGEN
PHARMACEUTICALS

net wt. 30 g (1 oz)

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75834-141
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75834-141-3030 g in 1 TUBE; Type 0: Not a Combination Product12/15/201611/15/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01512/15/201611/15/2024
Labeler - Nivagen Pharmaceuticals, Inc. (052032418)

Revised: 11/2024
Document Id: 229bb79b-6d7d-4416-a045-239d0e38fbed
Set id: e4565a04-1304-4f87-8d40-8a4ff72125ae
Version: 6
Effective Time: 20241119
 
Nivagen Pharmaceuticals, Inc.